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CTRI Number  CTRI/2025/08/092921 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Proprioceptive training protocol combined with kinesiotaping to improve balance in cerebral palsy children using pediatric balance scale 
Scientific Title of Study   Proprioceptive training regimen combined with kinesio taping to improve balance in spastic diplegic children using pediatric balance scale a cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snehal ankush rathod 
Designation  Graduate student 
Affiliation  Dr ulhas patil college of physiotherapy jalgaon 
Address  Dr ulhas patil college of physiotherapy khirdi shivar bhusawal jalgaon road
Dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road
Jalgaon
MAHARASHTRA
425507
India 
Phone  8329465312  
Fax    
Email  snehalrathod637@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Krutika ishwar kale 
Designation  Professor 
Affiliation  dr ulhas patil college of physiotherapy jalgaon 
Address  NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 425507 India
NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 425507 India
Jalgaon
MAHARASHTRA
425507
India 
Phone  9146890653  
Fax    
Email  kkrutikaa45@gmail.com  
 
Details of Contact Person
Public Query
 
Name  snehal ankush rathod 
Designation  Graduate student 
Affiliation  dr ulhas patil college of physiotherapy jalgaon 
Address  dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road
NH 06, Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon Maharashtra 4250001 India
Jalgaon
MAHARASHTRA
425507
India 
Phone  08329465312  
Fax    
Email  snehalrathod637@gmail.com  
 
Source of Monetary or Material Support  
Dr ulhas patil college of physiotherapy jalgaon maharashtra 425309 
 
Primary Sponsor  
Name  Dr krutika kale 
Address  Dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road 425507 maharashtra 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Drsnehal ankush rathod  dr ulhas patil college of physiotherapy jalgaon  physiotherapy department opd no 207 dr ulhas patil college of physiotherapy nh 06 gat no 57/1 khirdi shivar bhusawal jalgaon road
Jalgaon
MAHARASHTRA 
08329465312

snehalrathod637@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: F82||Specific developmental disorder ofmotor function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  proprioception exercises  1. Children having 6-12 years of age and who were clinically diagnosed with Spastic diplegic cerebral palsy were included in the study. 2. Prior consent was taken from their respective guardians and all their concerns and queries were respectfully answered. 3. The warm-up phase will last for 5 min and include the following exercises, each session lasted 40 min and followed the list of 6 exercises that we recommended in the exact order they are listed, from 1 to 6 , starting with • Taping protocol (5 Min) • Warm-up (5 Min) • Proprioceptive training (20 Min) • Cool-down (5 Min) 4. Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children diagnosed as spastic diplegic cerebral palsy
Age between 6 to 12 years
Both gender
Gross motor function level 1and 2
Written consent from their parents
Spasticity range between 1 and 1+ grade according Modified Ashworth scale in Gastrosoleus muscle.
 
 
ExclusionCriteria 
Details  Uncooperative childrens
Unstable medical conditions epilepsy cardiovascular disease
Sensory processing disorders that may interfere with taping interventions
Recent surgery or injury affecting mobility
Recent Fracture
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Pediatric Balance Scale
 
4.Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
 
 
Secondary Outcome  
Outcome  TimePoints 
2. Gross Motor Function Classification System  Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
 
3. Modified Ashworth Scale  Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted for 40 Mins including,
 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="28" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM 

To investigate the effectiveness of a proprioceptive training regimen

combined with kinesiotaping to improve balance in spastic diplegic childrens.

OBJECTIVE

1)     To analyze balance in spastic diplegic children’s using peadiatric balance scale.

  2)     To improve balance in spastic diplegic children’s by proprioceptive training regimen combined with kinesiotaping using pediatric balance scale.

  3)     To enhance balance in children with spastic diplegia, a 4 week protocol combining proprioceptive training and kinesiotaping was implemented, assessed using the pediatric balance scale.

Procedure

 1.     All participants will be screened as per the inclusion and exclusion criteria.

           2.     A written informed consent will be taken from their parents.

           3.     Demographic information will be collected of all participants.

          4.     GMFCS will be administered and only Level 1 and Level 2  Cerebral Palsy children will             be selected

         5.     Modified ashworth scale will be taken for assesing spasticity in gastrosoleus muscle  &               pediatric balance score to assess balance in participant pre intervention

         6.     Implement proprioceptive training regimen combined with tapping (4 week interventions

        7.     MAS will be taken for assesing spasticity in gastrosoleus muscle  & pediatric balance                  score to assess balance in participant  post  intervention

         8.     The collected data will be analyzed by using statistical tests and results will be generated 

      Intervention 

  1. Children having 6-12 years of age and who were clinically diagnosed with Spastic diplegic cerebral palsy were included in the study.
  2. Prior consent was taken from their respective guardians and all their concerns and queries were respectfully answered.
  3. The warm-up phase will last for 5 min and include the following exercises, each session lasted 40 min and followed the list of  6 exercises that we recommended in the exact order they are listed, from 1 to 6, starting with ,         Taping protocol (5 Min)

                                                                                         Warm-up (5 Min)

                                                                                          Proprioceptive training (20 Min)

                                                                                         Cool-down (5 Min) 

1.                     4 Intervention is given for 4 weeks, 3 sessions per week on alternate days. each session lasted                 for 40 Mins .

 

 

 

 

 

 
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